GERMANTOWN, Md.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE-MKT:SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, presented results of the PRECISE II U.S. pivotal trial at this week’s 16th Annual Diabetes Technology Meeting in Bethesda, Maryland.
The primary accuracy results demonstrate a mean absolute relative difference (MARD) of 8.8% over the full glycemic range for the entire 90-day sensor duration. The MAD in the low range (<80 mg/dL) was shown to be 9.6 mg/dL. A large data set of over 16,000 paired data points of sensor and YSI reference glucose values were collected and used in the accuracy analysis.
Significant findings also presented include:
- The strong accuracy was sustained throughout the 90-day sensor life. Performance across each of the 30-day intervals from the beginning, middle and end of sensor life remained consistent.
- Study results show 93% of readings were within 20% of the YSI reference.
- Excellent safety performance with no infections or skin irritation reported during the 9,700 sensor wear days; 14 device or procedure related adverse events in 7 subjects were reported with the most frequent cited (n=8) was mild bruising or erythema.
- The detection rate at the hypoglycemia alert setting (70 mg/dL) was 93% and 96% at the hyperglycemia alert setting (180 mg/dL).
- The system showed strong sensor survival with 94% of the subjects demonstrating continuous use through 90 days.
- Sub-analysis showed no accuracy impact from exercise or sensor compression
- Sub-analysis of the dataset if calibrated only 1time/day demonstrated a 9.5% MARD.
“We’re very pleased with the results from this very large and important US trial. We want to thank the very dedicated people with diabetes who participated in the study as well as all of our clinical investigators. We are committed to bringing an accurate, reliable and long-lasting CGM system to people with diabetes in the United States,” said Tim Goodnow, PhD., President and CEO of Senseonics. “We look forward to working with the FDA to receive approval as quickly as possible.”
As previously reported, the PRECISE II U.S. pivotal trial enrolled 90 adults with Type 1 or Type 2 diabetes at eight clinical centers. The objective of the study was to assess the safety and effectiveness of the Eversense® CGM system over 90 days of continuous glucose sensor wear. Participants in the study used the system’s smart transmitter and mobile app at home for the next 90 days. Calibration was performed twice a day, and Sensor glucose readings were calculated prospectively, but real-time glucose readings and trends were not made available to participants. Clinic visits were scheduled at approximately 30-day intervals in order to obtain lab reference glucose values for comparison with the sensor values and to evaluate hyperglycemic and hypoglycemic challenges in a controlled setting.
Senseonics has submitted to the U.S. Food and Drug Administration (FDA) a Premarket Approval (PMA) application for its Eversense® CGM system. Upon receiving FDA regulatory approval, Senseonics plans to initiate sales in the United States. The company received its CE mark in May 2016 and is currently marketing the Eversense CGM System in select European countries.
Eversense® CGM System is an Investigational Device and is limited by United States law to investigational use.
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ first generation continuous glucose monitoring (CGM) system, Eversense®, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels. For more information on Senseonics, please visit www.senseonics.com.